Darbepoetin alfa is a man-made form of a protein that helps your body produce red blood cells. The amount of this protein in your body may be reduced when you have kidney failure or use certain medications. When fewer red blood cells are produced, you can develop a condition called anemia.

Darbepoetin alfa is used to treat anemia (a lack of red blood cells in the body).

Darbepoetin alfa may also be used for purposes not listed in this medication guide.

You should not use this medication if you have untreated or uncontrolled high blood pressure, if you are allergic to darbepoetin alfa or epoetin alfa (Epogen or Procrit), or if you have ever had pure red cell aplasia (PRCA, a type of anemia) caused by using either of these two drugs.

Before using darbepoetin alfa, tell your doctor if you have heart disease, congestive heart failure, high blood pressure, kidney disease, a blood cell or clotting disorder, cancer, a seizure disorder, a latex allergy, or a history of stroke, heart attack, or blood clots.

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use darbepoetin alfa. Darbepoetin alfa may also shorten remission time or survival time in some people with certain types of cancer. Talk with your doctor about the risks and benefits of using darbepoetin alfa.

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain or heavy feeling, pain spreading to the arm or shoulder, shortness of breath, slurred speech, or problems with vision or balance.

To be sure this medication is helping your condition, your blood may need to be tested often. Your blood pressure will also need to be checked. Visit your doctor regularly.

Contact your doctor if you feel light-headed or unusually weak or tired. These may be signs that your body has stopped responding to darbepoetin alfa.

Some women using darbepoetin alfa have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.

You should not use this medication if you are allergic to darbepoetin alfa or epoetin alfa (Epogen or Procrit), or if you have:

• untreated or uncontrolled high blood pressure; or

• if you have ever had pure red cell aplasia (PRCA, a type of anemia) caused by using darbepoetin alfa or epoetin alfa.

To make sure you can safely take darbepoetin alfa, tell your doctor if you have any of these other conditions:

• heart disease, congestive heart failure, high blood pressure;

• kidney disease (or if you are on dialysis);

• a history of stroke, heart attack, or blood clots;

• a blood cell or clotting disorder, such as sickle cell anemia or hemophilia;

• cancer;

• a seizure disorder; or

• if you are allergic to latex.

FDA pregnancy category C. It is not known whether darbepoetin alfa will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether darbepoetin alfa passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Some women using darbepoetin alfa have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need to use birth control while you are using darbepoetin alfa.

Darbepoetin alfa may shorten remission time in some people with head and neck cancer who are also being treated with radiation. Darbepoetin alfa may also shorten survival time in certain people with breast cancer, non-small cell lung cancer, head and neck cancer, cervical cancer, or lymphoid cancer. Talk with your doctor about your individual risk.